Nivolumab NSCLC Approval Expanded to Perioperative Setting

The US Food and Drug Administration (FDA) has expanded the approval of nivolumab (Opdivo, Bristol Myers Squibb) for the treatment of certain patients with resectable non–small cell lung cancer (NSCLC).

Specifically, the immune checkpoint inhibitor — a programmed death receptor-1 (PD-1) blocking monoclonal antibody — has been approved for use in combination with platinum-doublet chemotherapy as neoadjuvant treatment, followed by adjuvant nivolumab monotherapy after surgery, in previously untreated adults with resectable stage IIA-IIIB disease and no known epidermal growth factor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Nivolumab is already approved for use in numerous solid tumors and blood cancers, including in the neoadjuvant setting for resectable NSCLC.

The new approval was based on safety and efficacy findings from the randomized, double-blind, placebo-controlled CheckMate 77T trial, according to the FDA approval notice. That trial of 461 patients demonstrated an event-free survival (EFS) benefit with neoadjuvant nivolumab vs placebo with platinum-based chemotherapy followed by adjuvant single-agent nivolumab vs placebo. The median EFS was not reached in the nivolumab arm and was 18.4 months in the placebo arm (hazard ratio [HR], 0.58).

A descriptive analysis at the prespecified interim analysis “revealed no detriment” with respect to overall survival, according to the FDA notice.

Patients were randomly assigned in a 1:1 ratio to the nivolumab or placebo arm. Neoadjuvant treatments were given every 3 weeks for up to four cycles, followed by adjuvant treatments every 4 weeks for up to 13 cycles. 

Safety was comparable to that seen in other clinical trials of nivolumab plus chemotherapy; 5.3% and 3.5% of patients in the nivolumab and placebo arms, respectively, were unable to undergo surgery due to adverse events. Surgery was delayed due to adverse events in 4.5% and 3.9% of patients in the arms, respectively.

The recommended neoadjuvant nivolumab dose is 360 mg every 3 weeks followed by 480 mg every 4 weeks in the adjuvant setting. When nivolumab and chemotherapy are administered on the same day, nivolumab should be administered first, according to the prescribing information available at Drugs@FDA. 

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at [email protected] or on Twitter: @SW_MedReporter.